MAUDE Adverse Event Report: COVIDIEN TRAILBLAZER ANGLED; CATHETER, PERCUTANEOUS

Catalog Number	ASC-035-150
Medical Device Problem Code	Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/30/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation summary: the angle trailblazer catheter was received for evaluation.The returned catheter was observed to be tangled and had a guidewire stuck inside the angle trailblazer catheter.Visual inspection of the angled trailblazer catheter shaft revealed multiple kinks to catheter shaft.All three marker bands were accounted for.The distal tip showed no abnormalities or deformities.The returned compatible 0.035in guidewire was observed to be damaged; the guidewire coating was torn and exposing the bare wire.There is evidence of twisting and kinking of the guidewire.The guidewire od was measure approximately 0.0335in.The guidewire was attempted to be retrieve from the catheter but was met with resistance and the guidewire was unable to be retrieved.There is evidence of accordion folding of the catheter underneath the strain relief.The customer experience of guidewire retrieval difficulty inside the angle trailblazer catheter was confirmed.The catheter shaft was sliced at the location, (approximately 22cm) where a 0.035in guidewire would not advance.The id was measured using a m-o model plus pin gage.The catheter lumen would accept pin gage sizes up to 0.035in.The cathet er lumen would not accept pin gage sizes 0.036in and higher.The catheter was sliced opened approximately 260cm to locate the distal end of the guidewire and verify if there were abnormalities.When the guidewire was removed from the catheter shaft, the distal tip appeared to be bent/kinked.Wet sanguine material was observed on the spring coil of the distal tip.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Physician intended to use a trailblazer angled catheter with a 6fr sheath and non-medtronic 0.035¿ guidewire for the treatment of a severely calcified, moderately tortuous plaque lesion in the right superficial femoral artery of diameter 5mm.Anatomy abnormalities reported as long chronic total occlusion (cto).It was reported that ifu was followed during preparation.The vessel was pre-dilated.It was reported that during procedure, the non-medtronic wire got stuck inside of the 0.035 angled trailblazer and could not be removed.Physician ended up losing access and could not re-cross the cto.The physician then stopped procedure and treated proximal sfa.There was no patient injury reported.

• Brand Name: TRAILBLAZER ANGLED
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 7023099
• Report Number: 2183870-2017-00498
• Device Sequence Number: 19180854
• Product Code: DQY
• UDI-Device Identifier: 20643169694945
• UDI-Public: 20643169694945
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K092299
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/01/2018
• Device Catalogue Number: ASC-035-150
• Device Lot Number: A368425
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2017
• Initial Report FDA Received Date: 11/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1